BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 10058961 · Received May 14, 2020

    Report

    Report Number
    2939274-2020-02349
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 1, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982070401
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: PART NUMBER: 03.037.024, LOT NUMBER: T111966, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: DECEMBER 22, 2104. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. VISUAL INSPECTION: THE HELICAL BLADE INSERTER (P/N: 03.037.024 , L/N: T111966) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE COMPLAINT DEVICE WAS MISSING THE HANDLE COMPONENT. THE COMPLAINT DEVICE WAS NOT OBSERVED TO BE BROKEN INTO SEPARATE PIECES. SCRATCHES/NICKS/DEFORMATIONS WERE OBSERVED ON THE CYLINDRICAL MID-SHAFT COMPONENT OF THE DEVICE AND ALONG THE MAIN SHAFT, WHICH WAS CONSISTENT WITH COSMETIC DAMAGE. YELLOW COLORED MARKING WERE OBSERVED TO BE MISSING ON 1 OF 2 SIDES OF CYLINDRICAL MID-SHAFT COMPONENT OF COMPLAINT DEICE. RED MARKINGS WERE OBSERVED TO BE MISSING FROM DISTAL END OF MAIN SHAFT AND BACK SIDE OF CYLINDRICAL MID-SHAFT COMPONENT OF COMPLAINT DEVICE. ADDITIONALLY, ETCHING OF PART AND LOT NUMBER WAS FADED. NO DAMAGE OR DEFECT WAS NOTED TO THE REMAINING FEATURES OR COMPONENTS OF THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WERE REVIEWED: CURRENT AND MANUFACTURED , SHAFT WELDED CURRENT AND MANUFACTURED , SHAFT CURRENT AND MANUFACTURED , HANDLE CURRENT AND MANUFACTURED NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DRAWING SPECIFIED DIMENSIONS: SHAFT (DISTAL OF CYLINDRICAL MID-SHAFT WELDED COMPONENT) OD = 15.8MM 0/-0.05MM MEASURED DIMENSIONS: SHAFT (DISTAL OF CYLINDRICAL MID-SHAFT WELDED COMPONENT) OD = CONFORMING DEVICE USED ¿ CALIPER CA592. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED AS THE COMPLAINT DEVICE WAS MISSING THE HANDLE COMPONENT AND WAS NOT OBSERVED TO BE BROKEN INTO SEPARATE PIECES. ADDITIONALLY, SCRATCHES/NICKS/DEFORMATIONS WERE OBSERVED ON THE CYLINDRICAL MID-SHAFT COMPONENT OF THE DEVICE AND ALONG THE MAIN SHAFT OF THE DEVICE. YELLOW COLORED MARKING WERE OBSERVED TO BE MISSING ON 1 OF 2 SIDES OF CYLINDRICAL MID-SHAFT COMPONENT OF COMPLAINT DEVICE. RED MARKINGS WERE OBSERVED TO BE MISSING FROM DISTAL END OF MAIN SHAFT AND BACK SIDE OF CYLINDRICAL MID-SHAFT COMPONENT OF COMPLAINT DEVICE. ADDITIONALLY, ETCHING OF PART AND LOT NUMBER WAS FADED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MISSING EPOXY WAS INVESTIGATED UNDER CAPA. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, NO NEW CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2020. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING HIP FRACTURE PROCEDURE THE HELICAL BLADE INSERTER WAS BROKEN. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) HELICAL BLADE INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520780 HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.024 T111966 10886982070401

    Patients

    Seq Age Sex Outcome Treatment
    1